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  • 312 Safety and efficacy of laparoscopic or robot-assisted radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasm (SOLUTION): perioperative outcomes of a multi-centre, non-inferiority phase II trial

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01. Cervical cancer
312 Safety and efficacy of laparoscopic or robot-assisted radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasm (SOLUTION): perioperative outcomes of a multi-centre, non-inferiority phase II trial
  1. Hee Seung Kim1,
  2. Soo Jin Park1,
  3. Yoo-Young Lee2,
  4. San Hui Lee3,
  5. Seung-Hyuk Shim4,
  6. Sung Jong Lee5,
  7. Maria Lee6,
  8. Suk-Joon Chang7,
  9. Taejong Song8,
  10. Myong Cheol Lim9,
  11. Chel Hun Choi2,
  12. Eun Ji Nam10 and
  13. Tae Wook Kong7
  1. 1Seoul National University College of Medicine, Seoul, South Korea
  2. 2Samsung Medical Center, Seoul, South Korea
  3. 3Wonju Severance Christian Hospital, Wonju, South Korea
  4. 4Konkuk University School of Medicine, Seoul, South Korea
  5. 5Seoul St. Mary’s Hospital, Seoul, South Korea
  6. 6Seoul National University Hospital, Seoul, South Korea
  7. 7Ajou University School of Medicine, Suwon, South Korea
  8. 8Kangbuk Samsung Hospital, Seoul, South Korea
  9. 9National Cancer Center, Goyang, South Korea
  10. 10Yonsei University College of Medicine, Seoul, South Korea

Abstract

Introduction/Background This study has been designed to evaluate the safety and efficacy of laparoscopic or robot-assisted radical hysterectomy using the endoscopic stapler for inhibiting tumour spillage in early-stage cervical cancer. So, we introduce perioperative outcomes of this study.

Methodology A multi-centre, non-inferiority phase II trial included 126 patients (age >20) with 2009 FIGO IB1 cervical cancer, including squamous cell carcinoma (SCC), endocervical adenocarcinoma (EA) and adenosquamous carcinoma (AC) between July 2020 and August 2023. The SOLUTION technique, which involves endoscopic stapler resection of the vagina, additional resection of the stapler vaginal stump, and endoscopic closure of the vaginal opening after specimen removal via it during type B1 to C2 hysterectomy.

Results Among all patients, 70 (56.5%), 50 (40.3%), 2 (1.6%), and 2 (1.6%) had SC, EA, AC, and endometrioid adenocarcinoma of the uterus. Robot-assisted and laparoscopic radical surgery were performed in 46 (37.1%) and 78 (62.9%), and conventional and sentinel lymph node dissection were performed in 90 (72.6%) and 34 (27.4%), respectively. Estimated blood loss, transfusion, operation time and hospitalization averaged 200 ml, 0, 184.5 min, and 6 days, and vaginal tube and intrauterine manipulator were used in 57 (46%) and 55 (44.4%) during surgery. Table 1 shows the detailed contents of the SOLUTION technique. On the pathologic examination, the tumour size was 21 mm (range, 0 to 59), and positive resection margin and lymph node metastasis were detected in 2 (1.6%) and 5 (4%). Intraoperative and postoperative complications were relatively rare except for one ureteral injury during endoscopic stapling.

Conclusion The SOLUTION technique may be feasible for preventing tumour spillage during laparoscopic or robot-assisted radical hysterectomy in early-stage cervical cancer. Further evaluation for the safety and efficacy is anticipated in terms of survival (Clinicaltrial.gov; No. NCT04370496).

Disclosures This study is supported by Johnson & Johnson.

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Abstract 312 Table 1

https://doi.org/10.1136/ijgc-2024-ESGO.150

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